Abdominal aortic aneurysms represent a dilatation and weakening of the abdominal aorta which can lead to aortic rupture and sudden death. Previously, the medical treatment of abdominal aortic aneurysms required complicated surgery with an associated high risk of injury to the patient. More recently, endografts (combining stents and grafts into a single device) have been developed that can be inserted through small incisions in the groin. Once in place, these endografts seal off the weakened section of the aorta. The aneurysms can then heal, eliminating the risk of sudden rupture. This less invasive form of treatment for abdominal aortic aneurysms has rapidly become the standard of care for this disease. An example of an endograft device is disclosed in Kornberg, U.S. Pat. No. 4,617,932.
A significant problem with endografts is that, due to inadequate sealing of the graft with the aorta, leaks can develop that allow blood to continue to fill the aneurysmal sac. Left undiscovered, the sac will continue to expand and potentially rupture. To address this situation, patients who have received endograft treatment for their abdominal aortic aneurysms are subjected to complex procedures that rely on injection of contrast agents to visualize the interior of the aneurysm sac. These procedures are expensive, not sensitive, and painful. In addition, they subject the patient to additional risk of injury. See, for example, Baum R A et al., “Aneurysm sac pressure measurements after endovascular repair of abdominal aortic aneurysms,” The Journal of Vascular Surgery, January 2001, and Schurink G W et al., “Endoleakage after stent-graft treatment of abdominal aneurysm: implications on pressure and imaging—an in vitro study,” The Journal of Vascular Surgery, August 1998. These articles provide further confirmation of the problem of endograft leakage and the value of intra-sac pressure measurements for monitoring of this condition.
Thus, there is a need for a method of monitor the pressure within an aneurysm sac that has undergone repair by implantation of an endograft to be able to identify the potential presence of endoleaks. Furthermore, this method should be accurate, reliable, safe, simple to use, inexpensive to manufacture, convenient to implant and comfortable to the patient.
An ideal method of accomplishing all of the above objectives would be to place a device capable of measuring pressure within the aneurysm sac at the time of endograft insertion. By utilizing an external device to display the pressure being measured by the sensor, the physician will obtain an immediate assessment of the success of the endograft at time of the procedure, and outpatient follow-up visits will allow simple monitoring of the success of the endograft implantation.
An example of an implantable pressure sensor designed to monitor pressure increases within an aneurysmal sac is shown in Van Bockel, U.S. Pat. No. 6,159,156. While some of the above objectives are accomplished, this device has multiple problems that would make its use impractical. For example, the sensor system disclosed in the Van Bockel patent relies on a mechanical sensing element that cannot be practically manufactured in dimensions that would allow for endovascular introduction. In addition, this type of pressure sensor would be subject to many problems in use that would limit its accuracy, stability and reliability. One example would be the interconnection of transponder and sensor as taught by Van Bockel, such interconnection being exposed to body fluids which could disrupt its function. This would impact the device's ability to maintain accurate pressure reading over long periods of time. A fundamental problem with sensors is their tendency to drift over time. A sensor described in the Van Bockel patent would be subject to drift as a result of its failure to seal the pressure sensing circuit from the external environment. Also, by failing to take advantage of specific approaches to electronic component fabrication, allowing for extensive miniaturization, the Van Bockel device requires a complex system for acquiring data from the sensor necessary for the physician to make an accurate determination of intra-aneurysmal pressure.